Electrical Nerve Stimulation for Nerve Injury

(REGAIN Trial)

Recruiting at 10 trial locations

Overseen By Tracy Cameron, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Epineuron Technologies Inc.

Disqualifiers: Peripheral neuropathy, active implanted device

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 hour

110 Participants Needed

Trial Summary

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Electrical Nerve Stimulation for Nerve Injury?

Research shows that peripheral nerve stimulation (PNS) is effective in reducing chronic pain from various conditions, including pain after amputation and knee surgery. It works by using electrical signals to block pain messages from reaching the brain, offering a promising non-drug option for managing pain. ^{1 2 3 4 5}

Is electrical nerve stimulation safe for humans?

Peripheral nerve stimulation (PNS) has been used safely since 1965 for treating pain, although some studies note a high rate of hardware-related issues that may require fixing. ^{3 4 6 7 8}

How is the Temporary Peripheral Nerve Stimulation System different from other treatments for nerve injury?

The Temporary Peripheral Nerve Stimulation System is unique because it uses electrical stimulation to target peripheral nerves, helping to block pain signals without the need for surgery or drugs. This noninvasive approach can be used temporarily to assess its effectiveness before considering a permanent implant, making it a flexible option for managing chronic pain from nerve injuries. ^{1 4 8 9 10}

What is the purpose of this trial?

A novel temporary peripheral nerve stimulation system that delivers a single dose of electrical stimulation therapy for 1 hour will be evaluated for safety and effectiveness.

Eligibility Criteria

This trial is for individuals who have recently suffered a peripheral nerve injury. It's not suitable for those with ongoing nerve conditions like peripheral neuropathy or anyone with an active implanted device, such as a pacemaker.

Inclusion Criteria

I have a nerve injury in my arms or legs.

Exclusion Criteria

Patients with any active implanted device

I do not have numbness, tingling, or pain in my hands or feet.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of electrical stimulation therapy for 1 hour

1 hour

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Sham Temporary Peripheral Nerve Stimulation System
• Temporary Peripheral Nerve Stimulation System

Trial Overview The study is testing the safety and effectiveness of a new temporary nerve stimulation system that delivers electrical therapy for one hour compared to a sham (inactive) version of the same system.

Participant Groups

Group I: Active treatment Experimental Treatment 1 Intervention

Group II: Sham treatment Placebo Group 1 Intervention

Temporary Peripheral Nerve Stimulation System is already approved in United States for the following indications:

Approved in United States as Sprint Peripheral Nerve Stimulation System for:

• Chronic intractable pain of peripheral nerve origin
• Postsurgical and posttraumatic acute pain

Who Is Running the Clinical Trial?

Epineuron Technologies Inc.

Lead Sponsor

Trials

3

Recruited

160+

Findings from Research

Temporary electrical stimulation of peripheral nerves and the spinal cord is an effective screening method to identify patients who may benefit from permanent stimulation systems for chronic pain relief.

This technique has shown a high success rate in selecting candidates for permanent implantation, particularly for those suffering from chronic pain due to nerve injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Uses of percutaneous electrical stimulation of the nervous system. Long, DM.[2011]

A novel percutaneous peripheral nerve stimulation (PNS) system was evaluated in 24 patients with residual or phantom limb pain after lower-extremity amputation, showing that 75% of participants experienced significant pain relief (≥50%) after up to 60 days of treatment.

The study indicates that percutaneous PNS not only reduces pain but also improves quality of life and function, suggesting it could be a beneficial therapy for Military Service members and Veterans dealing with chronic pain post-amputation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous Peripheral Nerve Stimulation for the Treatment of Chronic Pain Following Amputation. Cohen, SP., Gilmore, CA., Rauck, RL., et al.[2022]

In a retrospective study of 12 patients with saphenous neuralgia, peripheral nerve stimulation (PNS) showed promising results, with 83% of patients reporting symptom improvement after 6 months, indicating its potential as a non-pharmacologic treatment option.

The average change in pain interference scores at 6 months was 5.8, suggesting a meaningful reduction in pain, although complications were noted in 33% of patients, highlighting the need for careful patient selection and monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peripheral nerve stimulation for saphenous neuralgia. McCullough, M., Kenney, D., Curtin, C., et al.[2023]

Peripheral nerve stimulation (PNS) is an effective technique for managing various types of chronic and acute pain by using electrical stimulation to inhibit pain signal transmission in both central and peripheral pathways.

PNS works by inhibiting specific pain fibers in the central nervous system and downregulating inflammatory mediators and neurotransmitters involved in pain signaling, making it a versatile option for treating conditions like post-surgical pain, headaches, and phantom limb pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanism of Action of Temporary Peripheral Nerve Stimulation. Abd-Elsayed, A., Attanti, S., Anderson, M., et al.[2023]

In a case series of 19 patients with non-surgical osteoarthritic knee pain, the use of a temporary peripheral nerve stimulation (PNS) device for 60 days showed significant improvement in knee pain after the device was removed.

The results suggest that temporary PNS could be a promising treatment option for patients with limited therapeutic alternatives, highlighting the need for further high-quality research to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of peripheral nerve stimulation in refractory non-operative chronic knee osteoarthritis. Vangeison, CT., Bintrim, DJ., Helms, J., et al.[2023]

In a retrospective study of 46 patients with painful nerve injuries, peripheral nerve stimulation (PNS) provided good pain relief (50% or more reduction) in 78% of cases over a follow-up period of 3 to 16 years.

The average pain intensity significantly decreased from a visual analog scale (VAS) score of 69 before surgery to 24 after PNS, indicating that PNS is an effective long-term treatment option for selected patients with isolated painful neuropathies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term peripheral nerve stimulation for painful nerve injuries. Eisenberg, E., Waisbrod, H., Gerbershagen, HU.[2019]

The distal to proximal neurostimulator lead revision technique is a safe and effective method for adjusting lead positions in patients with chronic pain, as demonstrated in a case series of 3 patients.

All patients experienced over 50% pain reduction at long-term follow-up, indicating that this technique can provide significant relief without the need for replacing the entire neurostimulator system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A technique of distal to proximal revision of peripheral neurostimulator leads: technical note. Mammis, A., Mogilner, AY.[2014]

In a study of patients with chronic neuropathic pain who had previously responded to external noninvasive peripheral nerve stimulation (EN-PNS), all five participants reported continued use of the device and ongoing pain relief after an average of 3.5 years.

Pain intensity significantly decreased from an average of 5.6 to 3.5, and the worst pain reported dropped from 8.6 to 4.8, indicating that EN-PNS can provide long-term benefits for managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Treatment of Chronic Neuropathic Pain Using External Noninvasive External Peripheral Nerve Stimulation in Five Patients. Johnson, S., Goebel, A.[2022]

A case study of a 53-year-old woman with chronic lower extremity neuropathic pain showed that a design-specific peripheral nerve stimulation (PNS) device provided significant pain relief and improved functionality for two years after implantation.

This case highlights the effectiveness of modern PNS technology, suggesting it may be a preferable option over spinal cord stimulation for patients with isolated extremity pain, particularly those with spinal abnormalities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advancement in Neuromodulation Technology with the Innovation of Design-Specific Peripheral Nerve Stimulators: Sural Nerve Stimulation for Radiculopathy. Langford, B., Mauck, WD.[2021]

External noninvasive peripheral nerve stimulation (EN-PNS) showed significant short-term pain relief in patients with refractory neuropathic pain, with an average reduction of 2.8 points on a numerical rating scale after treatment.

In a study of 20 patients, 40% experienced improvements in quality of life and function, indicating that EN-PNS may be a beneficial option for managing chronic pain, although further controlled studies are needed to validate these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

External Noninvasive Peripheral Nerve Stimulation Treatment of Neuropathic Pain: A Prospective Audit. Johnson, S., Ayling, H., Sharma, M., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Uses of percutaneous electrical stimulation of the nervous system. [2011]

2. England pubmed.ncbi.nlm.nih.gov

Percutaneous Peripheral Nerve Stimulation for the Treatment of Chronic Pain Following Amputation. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Peripheral nerve stimulation for saphenous neuralgia. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Mechanism of Action of Temporary Peripheral Nerve Stimulation. [2023]

5. England pubmed.ncbi.nlm.nih.gov

The role of peripheral nerve stimulation in refractory non-operative chronic knee osteoarthritis. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Long-term peripheral nerve stimulation for painful nerve injuries. [2019]

7. Switzerland pubmed.ncbi.nlm.nih.gov

A technique of distal to proximal revision of peripheral neurostimulator leads: technical note. [2014]

8. United States pubmed.ncbi.nlm.nih.gov

Long-Term Treatment of Chronic Neuropathic Pain Using External Noninvasive External Peripheral Nerve Stimulation in Five Patients. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Advancement in Neuromodulation Technology with the Innovation of Design-Specific Peripheral Nerve Stimulators: Sural Nerve Stimulation for Radiculopathy. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

External Noninvasive Peripheral Nerve Stimulation Treatment of Neuropathic Pain: A Prospective Audit. [2022]